Medical device management review template

• Clinical Quality Management Plan Template

  The following is a detailed description of the Quarterly Quality Management review activities, which will be documented on the QM Quarterly Review Tool. Consent Process Completion and Documentation The site SC or designee will review X% of the site’s executed consents using the Quality Management Subject Data Review Tool.

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• BPI Pre-EUA.EUA Interactive Review Template Generic_20190730

  This interactive review template (the “template”) was designed to capture the data/information needed by the Food and Drug Administration (FDA) to support authorization of a product for ...

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• [DOCX File]Tool Summary Sheet: Clinical Monitoring Plan Template

  https://info.5y1.org/medical-device-management-review-template_1_72451b.html

  Review and provide training on the use of the electronic data capture system and the specimen management and tracking system for the study. Review Laboratory Supplies and Procedures Verify that the site has adequate supplies available as detailed in

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• [DOCX File]Medical Device Product Questionnaire

  https://info.5y1.org/medical-device-management-review-template_1_3afef0.html

  Biological material or derivate is used in the medical device. (If yes, specify origin (human, animal, recombinant or fermentation products or any other biological material; source (blood, bone, heart any other tissue or cells) and the intended reason for its presence …

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• [DOC File]Risk Management Plan Template

  https://info.5y1.org/medical-device-management-review-template_1_4cd333.html

  UP Template Version: 11/30/06 Note to the Author [This document is a template of a Risk Management Plan document for a project. The template includes instructions to the author, boilerplate text, and fields that should be replaced with the values specific to the project.

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• [DOC File]Sample Protocol Template - NHLBI, NIH

  https://info.5y1.org/medical-device-management-review-template_1_498536.html

  Medical Monitoring . Investigator only. Independent expert to monitor. Institutional Data and Safety Monitoring Board. Independent Data and Safety Monitoring Board. Definitions of Adverse Events. Classification of Events. Relationship. Severity. Expectedness. Data Collection Procedures for Adverse Events. Reporting Procedures. Adverse Event ...

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• [DOCX File]Managing Investigational Drugs/Devices

  https://info.5y1.org/medical-device-management-review-template_1_9c1002.html

  This is a template and should be used as such. Please use this in the manner most appropriate for your research unit. ... 21 CFR 803 Medical Device Reporting . 21 CFR 812 Investigational Device Exemptions . U S Food and Drug Administration (FDA) ... Review drug accountability at least prior to each monitor visit and at the end of the study. VIII.

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• [DOCX File]Medical Safety Template - Global Risk Assessments

  https://info.5y1.org/medical-device-management-review-template_1_ec7abc.html

  Therefore, it is a good management practice to review the assessments at least annually and update them on an ongoing basis, and especially following a major change in the physical environment. When reviewing the assessments, ask– ... Medical Safety Template - …

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• [DOC File]Functional Requirements Document Template

  https://info.5y1.org/medical-device-management-review-template_1_1e9098.html

  Identify the procedural and management requirements for review of the journal and follow-up action. 7.3.2 Audit Trail. Describe all user requirements for an audit trail, such as total transactions processed by location, time, type and retention periods. 7.3.2.1 Transactions Back to Original Source Documents

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• [DOCX File]Purpose - Medical Device Academy

  https://info.5y1.org/medical-device-management-review-template_1_327721.html

  Management Review inputs shall be documented in a presentation slide deck using a controlled template (FRM-023). The Management Representative shall assign responsibility for completing each slide of the presentation as an action item in the previous Management Review. These assignments shall be documented in the meeting minutes.

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